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Clinical Trials/NCT01037699
NCT01037699
Completed
Phase 3

Luteinizing Hormone (LH) Supplementation in Gonadotropin-releasing Hormone (GnRH) Antagonist Cycles

Instituto Valenciano de Infertilidad, IVI VALENCIA1 site in 1 country720 target enrollmentJanuary 2005

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Ovarian Stimulation
Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA
Enrollment
720
Locations
1
Primary Endpoint
Implantation rate
Status
Completed
Last Updated
16 years ago

Overview

Brief Summary

To analyse the impact on cycle outcome of LH supplementation in ovarian stimulation controlled with a GnRH antagonist in two ages groups: patients upto 35 years old, and patients aged between 36 and 39 years old.

Detailed Description

All patients received an oral contraceptive pill with 0.030 mg of ethinyl-estradiol and 3.0 mg of drospirenone the cycle prior to ovarian stimulation. On the second day of menstruation, patients started ovarian stimulation as follows: Patients \< 36: 225 IU/day of recombinant FSH (FSH alone group) or 150 IU of rFSH and 75 IU of rLH/day (FSH+LH group) for 5 days. On day 6, a 0.25 mg/day dose of the GnRH antagonist Cetrorelix is added until the day of rCG administration. Patients 36-39: Initial dose of 300 IU of rFSH /day (FSH alone group)) or 225 IU of rFSH and 75 IU of rLH/day (FSH + LH group) for 5 days. On day 6, a 0.25 mg/day dose of the GnRH antagonist Cetrorelix is added until the day of rCG administration. A maximum of 3 embryos were transferred on day 3 of embryo development.

Registry
clinicaltrials.gov
Start Date
January 2005
End Date
March 2008
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA

Eligibility Criteria

Inclusion Criteria

  • 1st-2nd IVF cycle.
  • Age until 39 years old
  • BMI: 18-29.
  • Basal FSH \< 12 IU/L

Exclusion Criteria

  • LH:FSH \> 2 (PCO)
  • Low response background (\< 5 oocytes)
  • Endometrioma
  • Recurrent pregnancy loss
  • Any preimplantational genetic diagnosis indication
  • Any systemic, metabolic or endocrinological disorder.

Outcomes

Primary Outcomes

Implantation rate

Time Frame: 4 weeks after embryo transfer

Study Sites (1)

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